Effectiveness of pregabalin in treatment of carpal tunnel syndrome: A Randomized controlled trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- A. SSS(Symptom Severity Score)
研究概览
简要总结
Carpal tunnel syndrome(CTS) is a chronic compressive neuropathy that is caused by median nerve entrapment in the carpal tunnel and is the most common entrapment neuropathy. The incidence of CTS in general population is approximately 1 in 1000. The prevalence of the disease is 5.3% in women and 2.1% in men. Risk factors for the development of CTS is obesity, pregnancy, diabetes, hypothyroidism, rheumatoid arthritis, trauma etc. Carpal tunnel is a osteo-fibrous canal that contains 9 flexor tendons and median nerve. CTS is manifested by paresthesia, numbness, tingling, pain( nocturnal), weakness or thenar atrophy. It is critical to begin treatment in early phase of CTS before the damage process.
Treatment modalities include conservative management which includes oral analgesics, splinting in mild to moderate CTS. Tropical steroid injection and decompressive surgery is also advised in severe CTS. Surgery is also indicated when sign and symptoms of CTS are persistent and interferes with quality of life.
Gabapentin and pregabalin are proposed for the treatment of neuropathic pain like diabetic neuropathy, herpetic neuralgia or trigeminal neuralgia. Gabapentin use is shown to be safe and effective in CTS but at a very high dose 900-1800 mg /day which can have some side effects or intolerable for some patients. Though pregabalin is also commonly used for various causes of neuropathic pain can be used in CTS. But there is no pregabalin vs placebo or pregabalin vs gabapentin comparision to suggest superiority of one over other.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •patients with symptoms & signs of CTS(idiopathic) with at least one of the following electrophysiological features- A.Difference in Median and Ulnar sensory peak Latency>0.5ms B.Difference in Median and Ulnar motor distal latency >0.5ms C.Median sensory latency ≥3.6ms D.Median motor distal Latency ≥4.5ms.
排除标准
- •A.Severe CTS with thenar atrophy B.Previously operated for release of Carpal Tunnel or local steroid injection C.Secondary causes of CTS like Diabetes mellitus, rheumatoid arthritis, hypothyroidism, amyloidosis and post-traumatic D.Patients with other neurological causes like polyneuropathies, thoracic outlet syndrome, cervical radiculopathy E.Patients in whom ultrasound reveal secondary causes of carpal tunnel syndrome like Ganglion cysts, accessory muscles etc F.Not willing to participate/give consent G.Pregnant or breast feeding women H.
- •Clinically significant cardiovascular, renal or hepatic disease I.
- •Patients on pregabalin for other casuse like seizure disorder, trigeminal neuralgia.
结局指标
主要结局
A. SSS(Symptom Severity Score)
时间窗: baseline,2 weeks,8 weeks
Change in BCTQ(Boston Carpal Tunnel Questionnaire) subscale score
时间窗: baseline,2 weeks,8 weeks
B. FSS(Functional Status Score)
时间窗: baseline,2 weeks,8 weeks
次要结局
- Change in clinical grading of CTS(Baseline, 8 week)
- Change in Electro-physiological grading of CTS(Baseline, 8 week)
- Change in grip strength by hydraulic hand dynamometer(Baseline, 2 week, 8 week)